1.  2011 Johns Hopkins Bloomberg School of Public Health Regulation of Tobacco Products Mitch Zeller, JD Pinney Associates

2.  2011 Johns Hopkins Bloomberg School of Public Health 2 Competing Visions The status quoA different path Unregulated products Unfettered access to the marketplace Evolving marketplace and morphing industry Proliferation of the “light cigarettes” disaster in LMICs Unproven claims to reduce exposure and risk Public health–based and science-driven regulation can change the status quo - Under FCTC Articles 9-11 or relevant national legislation (as in the United States) It will end the historical marketplace free-for-all - Where the tobacco industry controlled much of the evidence hiding what they didn’t want the public to see - Where government and the public health community were forced to play “catch-up” with the science

3.  2011 Johns Hopkins Bloomberg School of Public Health 3 Key Questions Why regulate tobacco products? What would tobacco product regulation consist of?  The problem with unregulated health claims What are the key provisions in the US Food and Drug Administration (FDA) tobacco bill? What is the future of global tobacco regulation? What are the basic building blocks for effective regulation of tobacco products?

4.  2011 Johns Hopkins Bloomberg School of Public Health Rationale for Tobacco Product Regulation Section A

5.  2011 Johns Hopkins Bloomberg School of Public Health 5 Why Regulate Tobacco Products? Some believe the public is already aware of the health risks associated with tobacco products, so regulation is not needed Others question why tobacco products are sold at all if they are so dangerous Prohibition will not work because most tobacco users are addicted to nicotine A “black market” could be more dangerous because of questionable ingredient quality and product purity

6.  2011 Johns Hopkins Bloomberg School of Public Health 6 What Would Tobacco Product Regulation Consist Of? Traditional regulation of consumer products is designed to ensure that ingredients and components are safe and products work as promised Under a traditional regulation model, such as the one employed by the US FDA for foods, product regulation would include:  Independent evaluation of health claims  Scientific support for product claims  Evidence submitted before claims are made  The Agency deciding if there is adequate scientific evidence to support the claim  Example: the cereal industry

7.  2011 Johns Hopkins Bloomberg School of Public Health 7 The Problem with Unregulated Health Claims In the current unregulated market for tobacco products, cigarette manufacturers are free to make any claims about their products  Smokers have no way of knowing whether claims promising to reduce exposure to cancer-causing chemicals in smoke are actually true  Example: “lights” cigarettes Source: Institute for Global Tobacco Control. (2011).

8.  2011 Johns Hopkins Bloomberg School of Public Health 8 What Would Tobacco Product Regulation Consist Of? Under a regulation model such as the one employed by the US FDA, tobacco product regulation would include:  Independent evaluation of health claims  Independent evaluation of the safety of new ingredients before they can be added to a tobacco product  Restriction of the level of harmful compounds to which tobacco users are exposed  Marketplace surveillance to ensure products are being used as intended

9.  2011 Johns Hopkins Bloomberg School of Public Health 9 US FDA and Tobacco Regulation In 1996, the FDA asserted jurisdiction, determining that:  Nicotine in tobacco products was a drug  Tobacco products were devices for the delivery of the drug nicotine 1996 FDA regulation restricted sales and marketing of tobacco products to young people FDA was sued by tobacco manufacturers, growers, retailers, and advertisers, claiming the agency’s actions were illegal

10.  2011 Johns Hopkins Bloomberg School of Public Health 10 US FDA and Tobacco Regulation In 2000, the US Supreme Court stripped the FDA of legal authority over tobacco products  Court ruled that it was not intended that the FDA should have these powers  The only way for the FDA to get back in the business of regulating tobacco products was to be through new legislation Tobacco industry argument  If the FDA had this power, they would have to ban tobacco products in the United States In 2009, Congress passed and President Obama signed into law the Family Smoking Prevention and Tobacco Control Act (FSPTCA)

11.  2011 Johns Hopkins Bloomberg School of Public Health Key Provisions Five things to know about the FSPTCA Important to global tobacco efforts—even those legally limited to the United States FDA’s approach is likely to influence global action under FCTC Articles 9, 10, 11 So let’s hope the FDA gets it right 11

12.  2011 Johns Hopkins Bloomberg School of Public Health 1. New Chapter, New Standard Not “safety and efficacy” but “appropriate for the protection of public health” With the right set of population-level considerations (impact on initiation, cessation, reduction of harm) 12

13.  2011 Johns Hopkins Bloomberg School of Public Health 2. Pre-Market Evaluation … with Some Exceptions Key principle of all food and drug law Will apply to new tobacco products and health-related claims Exception for “substantially equivalent” products 13

14.  2011 Johns Hopkins Bloomberg School of Public Health 3. Product Standards Powerful regulatory tool to control emissions Includes authority to reduce nicotine to non-addictive levels 14

15.  2011 Johns Hopkins Bloomberg School of Public Health 4. Disclosure of Industry Knowledge “Hey Philip Morris … tell us what you know” FDA to receive brand-specific information on ingredients, nicotine delivery, and any smoke constituent FDA identifies as harmful or potentially harmful Companies must also provide FDA with documents related to health, toxicological, behavioral, or physiologic effects of current or future products 15

16.  2011 Johns Hopkins Bloomberg School of Public Health 5. Program Security Funding for the new FDA Tobacco Center is assured (we think) Funded through “user fees” on the companies … really a market share assessment on each company Budget rises from $85 million to $712 million annually over first 11 years 16

17.  2011 Johns Hopkins Bloomberg School of Public Health 17 What Is the Future of Global Tobacco Regulation? World Health Organization (WHO) Framework Convention on Tobacco Control  Opportunity to bring about global tobacco regulation WHO taking significant steps to prepare the science base for effective product regulation around the world WHO created two entities  Tobacco Regulation (TobReg): study group on tobacco product regulation  Tobacco Laboratory Network (TobLabNet): affiliation of dozens of testing laboratories around the world strengthening capacity to test tobacco product contents and emissions